Ursolic Acid-Standardized Apple Pomace Supplementation for Muscle Strength and Physical Performance in Older Adults With Mild Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled Trial

NCT07562698 | Not Yet Recruiting DMC

• 1 other identifier: LUMHS-UA-SARC-2026-01
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sarcopenia is an age-related condition characterized by loss of muscle strength and physical performance, leading to increased risk of falls and disability. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of ursolic acid-standardized apple pomace supplementation on muscle strength and physical performance in older adults with mild sarcopenia. Participants will be randomly assigned to receive either 200 mg/day, 400 mg/day of the supplement, or placebo for 12 weeks. The primary outcome is change in handgrip strength, with additional assessments of physical performance, body composition, fatigue, and quality of life. The study will also evaluate the safety and tolerability of the intervention.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in handgrip strength from baseline

  Handgrip strength will be measured in kilograms using a calibrated hand dynamometer. The best value from three attempts on the dominant hand in a standardized seated position will be recorded. The outcome represents the change from baseline.

  Baseline to Week 12

Secondary Outcomes (7)

• Change in five-times chair stand test time

  Baseline to Week 12

• Change in Short Physical Performance Battery (SPPB) score

  Baseline to Week 12

• Change in gait speed

  Baseline to Week 12

• Change in Timed Up and Go test time

  Baseline to Week 12

• Change in body composition

  Baseline to Week 12

Study Arms (3)

Ursolic Acid 200 mg/day

EXPERIMENTAL

Participants will receive ursolic acid-standardized apple pomace extract tablets at a total daily dose of 200 mg for 12 weeks. The dosing regimen consists of one 200 mg active tablet taken at breakfast and one placebo tablet taken at dinner.

Dietary Supplement: Ursolic Acid-Standardized Apple Pomace Extract; Other: Placebo

Ursolic Acid 400 mg/day

EXPERIMENTAL

Participants will receive ursolic acid-standardized apple pomace extract tablets at a total daily dose of 400 mg for 12 weeks. The dosing regimen consists of one 200 mg active tablet taken at breakfast and one 200 mg active tablet taken at dinner.

Dietary Supplement: Ursolic Acid-Standardized Apple Pomace Extract

Placebo

ACTIVE COMPARATOR

Participants will receive matching placebo tablets identical in appearance to the active supplement, administered as one tablet at breakfast and one tablet at dinner for 12 weeks.

Other: Placebo

Interventions

Ursolic Acid-Standardized Apple Pomace Extract DIETARY_SUPPLEMENT

Oral supplementation with ursolic acid-standardized apple pomace extract formulated with phospholipids. The product is standardized to contain triterpenes including ursolic acid and is administered as tablets.

Also known as: Apple pomace extract, Ursolic acid supplement

Ursolic Acid 200 mg/day; Ursolic Acid 400 mg/day

Placebo OTHER

Matching placebo tablets identical in appearance, taste, and packaging to the active supplement, administered orally.

Placebo; Ursolic Acid 200 mg/day

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 to 80 years (inclusive)
• Male or female
• Community-dwelling outpatients
• Able and willing to provide written informed consent
• Able to comply with study procedures and attend scheduled visits
• Able to walk independently (assistive devices permitted) and safely perform physical performance assessments
• Stable medical condition and stable medication regimen for at least 4 weeks prior to screening
• Mild sarcopenia defined as:
• SARC-F score ≥4 or clinical suspicion of sarcopenia, and
• Low muscle strength defined as:
• Handgrip strength \<27 kg for men or \<16 kg for women, or Five-times chair stand test \>15 seconds or inability to complete without use of arms
• \- Eligible for body composition assessment using bioelectrical impedance analysis (BIA)

You may not qualify if:

• Severe sarcopenia or severe functional impairment precluding safe participation
• Unstable or uncontrolled medical conditions that may interfere with participation or safety
• Severe renal or hepatic disease, including:
• eGFR \<30 mL/min/1.73 m²
• Significant liver disease or markedly abnormal liver function tests
• Uncontrolled endocrine or metabolic disorders
• Active malignancy or ongoing cancer treatment
• Use of medications affecting muscle mass or function, including:
• Chronic systemic corticosteroids
• Anabolic steroids or testosterone therapy
• Other investigational muscle-modifying agents
• Recent structured resistance training within the past 3 months
• Use of muscle-targeted supplements (e.g., creatine, HMB) within the previous 4-8 weeks
• Contraindications to BIA (e.g., pacemaker or implanted electronic device)
• Acute illness within 4 weeks prior to screening

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Amjad Khan, DPhil

CONTACT

03330506955; amjadkhan@lumhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. Study products and placebo are identical in appearance, packaging, and administration schedule. Unblinding is permitted only in case of medical necessity.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized in a 1:1:1 ratio to receive either 200 mg/day ursolic acid-standardized apple pomace supplementation, 400 mg/day supplementation, or placebo for 12 weeks. Each participant will remain in their assigned group throughout the study period.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04